Events

Avis De Sécurité sur heartmate 3 system for left chamber, catalog no. 106524int - lvas hm3 set

Selon Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Poland qui a été fabriqué par Abbott.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    533
  • Date
    2018-06-08
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/uzupe%C5%82nienie-notatki-bezpiecze%C5%84stwa-fa-q118-mcs-1-firmy-abbott-dotycz%C4%85cej-systemu-heartmate-3-do
  • Notes / Alertes
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
  • Notes supplémentaires dans les données
  • Action
    Supplementing the safety note (FA-Q118-MCS-1) from Abbott regarding the HeartMate 3 System for Left Chamber Assistance, cat. No. 106524INT - LVAS HM3 kit

Device

heartmate 3 system for left chamber, catalog no. 106524int - lvas hm3 set

Manufacturer

Abbott
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ORMPMDBP